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news.Morphotek, a subsidiary of Eisai, has commenced a multi-centered Phase II study which will evaluate MORAb-009, its monoclonal antibody plus the chemotherapy drug gemcitabine, as a first line treatment for patients with pancreatic cancer.
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The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine. The primary objective of the study is to assess the efficacy of MORAb-009 as determined by overall survival in patients with locally advanced or metastatic pancreatic cancer. Secondary objectives include safety and anti-tumor activity of MORAb-009 as determined by objective response rate and progression free survival.
The patient population includes individuals with adenocarcinoma of the pancreas that cannot be cured by surgery and who have had no other chemotherapy for pancreatic cancer. Morphotek expects to enroll up to 152 patients in this clinical study, which is being conducted at clinical centers in North America, South America and Europe.
MORAb-009 is a monoclonal antibody that blocks the function of mesothelin, a cell surface protein on pancreatic tumor cells that can allow the tumor cells to attach, metastasize and grow. Preclinical studies have shown that MORAb-009 works additively with gemcitabine to suppress tumor growth.